{"id":"hypotonic-fluid","safety":{"commonSideEffects":[{"rate":null,"effect":"Hyponatremia (if administered too rapidly)"},{"rate":null,"effect":"Cerebral edema (in severe cases of overcorrection)"},{"rate":null,"effect":"Phlebitis at infusion site"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"Hypotonic solutions (such as 0.45% saline or 5% dextrose in water) have a lower osmotic pressure than plasma, causing water to shift from the extracellular space into cells. This mechanism is used clinically to treat hypernatremia and hyperosmolar states by restoring cellular hydration and normalizing serum osmolality.","oneSentence":"Hypotonic fluid reduces serum osmolality by providing free water, promoting water movement into cells and reducing extracellular fluid volume.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-28T01:15:20.134Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Hypernatremia management"},{"name":"Hyperosmolar dehydration"},{"name":"Cellular dehydration"}]},"trialDetails":[{"nctId":"NCT07189091","phase":"PHASE4","title":"CReep and Maintenance flUid Sodium Chloride ADministration rEduction in cRitically Ill adultS","status":"RECRUITING","sponsor":"University Hospital, Antwerp","startDate":"2025-10-07","conditions":"Critical Care, Intensive Care, Fluid Accumulation, Fluid and Electrolyte Imbalance","enrollment":640},{"nctId":"NCT01869010","phase":"","title":"Severe Impairment of Solute-Free Water Clearance in Patients With HIV Infection","status":"COMPLETED","sponsor":"Hospital Italiano de Buenos Aires","startDate":"2010-01","conditions":"HIV Infection","enrollment":30},{"nctId":"NCT05411991","phase":"PHASE4","title":"Diuretic Treatment in Acute Heart Failure With Volume Overload Guided by Serial Spot Urine Sodium Assessment","status":"COMPLETED","sponsor":"Vrije Universiteit Brussel","startDate":"2022-06-12","conditions":"Acute Heart Failure, Diuretics Drug Reactions","enrollment":107},{"nctId":"NCT06020495","phase":"PHASE3","title":"Systematic Use of DDAVP to Prevent Serum Sodium Overcorrection in Severe Hyponatremia","status":"RECRUITING","sponsor":"Assistance Publique - Hôpitaux de Paris","startDate":"2024-12-17","conditions":"Hyponatremia","enrollment":260},{"nctId":"NCT06251713","phase":"NA","title":"Fluid-removal Guided by VeXUS Score With Usual Care in Patients With Acute Kidney Injury After Cardiac Surgery","status":"RECRUITING","sponsor":"Hospices Civils de Lyon","startDate":"2024-07-31","conditions":"Acute Kidney Injury, Cardiac Surgery, Venous Congestion","enrollment":40},{"nctId":"NCT06484608","phase":"NA","title":"Comparison of Isotonic Versus Hypotonic Fluids in Neonates for Maintenance Fluid Therapy After Surgery","status":"COMPLETED","sponsor":"Rawalpindi Medical College","startDate":"2023-01-01","conditions":"Hyponatremia, Hypernatremia, Postoperative Care in Neonates","enrollment":84},{"nctId":"NCT04781361","phase":"","title":"Comparison of the Isotonic and Hypotonic Intravenous Maintenance Fluids In Term Newborns: Neofluid Study","status":"COMPLETED","sponsor":"Dokuz Eylul University","startDate":"2020-12-30","conditions":"Newborn Complication, Hyponatremia of Newborn, Hypernatremia of Newborn","enrollment":420},{"nctId":"NCT03092245","phase":"PHASE2","title":"Vasculopathic Injury and Plasma as Endothelial Rescue in Septic Shock (SHOCK) Trial","status":"COMPLETED","sponsor":"Rigshospitalet, Denmark","startDate":"2017-04-18","conditions":"Septic Shock","enrollment":44},{"nctId":"NCT00457873","phase":"PHASE3","title":"Isotonic Versus Hypotonic Fluid for Maintenance IV Therapy","status":"COMPLETED","sponsor":"McGill University Health Centre/Research Institute of the McGill University Health Centre","startDate":"2007-01","conditions":"Gastroenteritis, Bronchiolitis, Sepsis","enrollment":38},{"nctId":"NCT04117607","phase":"PHASE1","title":"Safety and Pharmacokinetics of Rezafungin","status":"TERMINATED","sponsor":"National Institute of Allergy and Infectious Diseases (NIAID)","startDate":"2019-12-04","conditions":"Fungal Infection","enrollment":14},{"nctId":"NCT03831997","phase":"","title":"Effect of Different Intravenous Fluids on Post-operative Chronic Subdural Hematoma Size and Recurrence","status":"UNKNOWN","sponsor":"Carilion Clinic","startDate":"2019-01-17","conditions":"Chronic Subdural Hematoma","enrollment":35},{"nctId":"NCT04402190","phase":"","title":"Hypotonic Hyponatremia: Criteria for the Correct Classification of Its Etiology and of Patient Volume Status","status":"COMPLETED","sponsor":"A.O.U. Città della Salute e della Scienza","startDate":"2018-06-01","conditions":"Hyponatremia, Hyponatremia With Extracellular Fluid Depletion, Hyponatremia With Normal Extracellular Fluid Volume","enrollment":123},{"nctId":"NCT02926989","phase":"PHASE4","title":"Intravenous Fluids in Hospitalised Children","status":"COMPLETED","sponsor":"University of Oulu","startDate":"2016-10-03","conditions":"Hypokalemia, Hyponatremia, Hypernatremia","enrollment":660},{"nctId":"NCT03840629","phase":"","title":"Fluid Tonicity and Hyponatraemia Post Surgery","status":"COMPLETED","sponsor":"National University Hospital, Singapore","startDate":"2014-11-13","conditions":"Hyponatremia, Surgery, Fluid and Electrolyte Imbalance","enrollment":659},{"nctId":"NCT03304197","phase":"NA","title":"Hydration and Exercise Performance in Cycling","status":"COMPLETED","sponsor":"University of Exeter","startDate":"2017-09-11","conditions":"Healthy","enrollment":15},{"nctId":"NCT02822898","phase":"PHASE4","title":"Metabolism of Isotonic Versus Hypotonic Maintenance Solutions in Fasting Healthy Adults","status":"COMPLETED","sponsor":"University Hospital, Antwerp","startDate":"2016-06","conditions":"Healthy Adult Volunteers","enrollment":12},{"nctId":"NCT00749827","phase":"PHASE4","title":"Renoprotective Effects of Fluid Prophylaxis Strategies for Contrast Induced Nephropathy (CIN)","status":"WITHDRAWN","sponsor":"Memorial University of Newfoundland","startDate":"","conditions":"Contrast Induced Nephropathy","enrollment":""},{"nctId":"NCT02667977","phase":"NA","title":"Reexamining Hypotonic Intravenous Fluid Use","status":"WITHDRAWN","sponsor":"Ann & Robert H Lurie Children's Hospital of Chicago","startDate":"2014-10","conditions":"Hyponatremia","enrollment":""},{"nctId":"NCT00734214","phase":"PHASE3","title":"Hypotonic Versus Isotonic Parenteral (HIP) Fluid Trial","status":"COMPLETED","sponsor":"Hamilton Health Sciences Corporation","startDate":"2008-03","conditions":"Hyponatremia, Hypernatremia","enrollment":258},{"nctId":"NCT00632775","phase":"PHASE3","title":"0.9% NaCl/Dextrose 5% vs 0.45% NaCl/Dextrose 5% as Maintenance Intravenous Fluids in Hospitalized Children","status":"COMPLETED","sponsor":"The Hospital for Sick Children","startDate":"2007-12","conditions":"Hyponatremia","enrollment":110},{"nctId":"NCT01301274","phase":"NA","title":"0.9% NaCl/Dextrose 5% vs 0.45% NaCl/Dextrose 5% as Maintenance Intravenous Fluids in Critically Ill Children","status":"COMPLETED","sponsor":"Hospital General de Niños Pedro de Elizalde","startDate":"2011-02","conditions":"Hyponatremia","enrollment":66},{"nctId":"NCT00621348","phase":"PHASE3","title":"Maintenance Intravenous Fluids in Children","status":"COMPLETED","sponsor":"All India Institute of Medical Sciences","startDate":"2006-09","conditions":"Hyponatremia","enrollment":167},{"nctId":"NCT01025583","phase":"PHASE2, PHASE3","title":"Oral Rehydration Solution With Zinc and Prebiotics in Acute Diarrhea","status":"COMPLETED","sponsor":"Federico II University","startDate":"2007-11","conditions":"Diarrhea","enrollment":130}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":162,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":["Hypotonic fluid,","0.2 % saline in 5 % dextrose","0.2 % saline in 5% dextrose"],"phase":"phase_3","status":"active","brandName":"Hypotonic fluid","genericName":"Hypotonic fluid","companyName":"All India Institute of Medical Sciences","companyId":"all-india-institute-of-medical-sciences","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Hypotonic fluid reduces serum osmolality by providing free water, promoting water movement into cells and reducing extracellular fluid volume. Used for Hypernatremia management, Hyperosmolar dehydration, Cellular dehydration.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}